A Culturally Tailored Dietary Intervention to Treat Crohn's Disease

Study Purpose

The goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. The intervention diet: DAIN has been adapted from the Inflammatory Bowel Disease Anti-Inflammatory Diet or IBD-AID™ taking into account the food availability and preferences of Puerto Ricans. DAIN also includes traditional foods commonly consumed in the typical Puerto Rican diet while maintaining the fundamental components of the IBD-AID™.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 21 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 21 to 65 years old.
  • - Confirmed Crohn's disease diagnosis is with mild to moderate Crohn's disease symptoms (sCDAI>220 <450) - Stable doses of medications are screened; thiopurines, natalizumab, vedolizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab (8 weeks), 5-aminosalicylic acid (5-ASA) (2 weeks), steroids (1 week) - Willingness and capacity to significantly change diet (arm 1) - Willing and able to comply with specimen collection and other study procedures, and to complete the study.

Exclusion Criteria:

  • - Ostomy.
  • - Use of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screening.
  • - Use of prescribed probiotics within 4 weeks of screening.
  • - > 20mg prednisone or equivalent.
  • - Recent C.
difficile colitis.
  • - Pregnancy.
- Presence of symptomatic or significant structure or history of obstruction in the past 6 months

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Massachusetts, Worcester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ana L Maldonado-Contreras, PhD
Principal Investigator Affiliation University of Massachusetts Chan Medical School
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Puerto Rico, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Additional Details

Crohn's disease is a chronic recurrent inflammatory disorder of the gastrointestinal that results from an inappropriate inflammatory response to an altered gut microbiome (i.e., dysbiosis). Diet is the main driver of microbiome composition. Diet also has been increasingly recognized as a cost-effective strategy to induce remission in pediatric and adult patients with Crohn's disease but diets that can substitute traditional and locally available foods among Puerto Ricans have not been explored. DAIN, a newly created dietary program, incorporates an extensive patient curriculum of recipes and menus adapted to the local availability and food preferences of Puerto Rican patients with Crohn's disease. This study aims to address three questions: whether DAIN a diet adapted to Puerto Rican patients with Crohn's disease, can: 1) induce clinical response and remission; 2) change the inflammatory tone, and 3) revert dysbiosis in Crohn's disease patients. Participants will be randomized 1:1 ratio into two arms:

  • - Arm 1 Crohn's disease patients + DAIN (Experimental): this group of patients will participate in ten weeks of DAIN intervention (From week 1 to week 10) - Arm 2 Crohn's disease patients no intervention (Control): this group of patients will not participate in the DAIN dietary intervention and will continue the usual diet.
Participation in the study lasts for 15 weeks with four-time points: week 0 (baseline), week 6, week 10, and week 14. At each time point, all subjects will complete a series of questionnaires to assess overall health, Crohn's disease activity, and dietary compliance. Blood and stool samples will be also collected at home at each time point. Samples will be either shipped or brought to the Research Unit at the Inflammatory Bowel Disease Clinic at the University of Puerto Rico. The primary outcome is clinical response and remission. Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, and (iii) dietary compliance.

Arms & Interventions


Experimental: Arm1: Crohn's disease patients + DAIN

Participants will have 10 weeks of DAIN intervention (From week 1 to week 10)

No Intervention: Arm 2: Crohn's disease patients no intervention

Participants will continue consuming their usual diet, with no intervention


Other: - DAIN

Participants in the experimental arm will have access to the newly created DAIN curriculum including menus, recipes, and recorded 'how to' recipes. Participants in the experimental arm will also have once-per-week dietary counseling with DAIN-trained nutritionists and monthly cooking classes with a DAIN-trained chef.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Worcester, Massachusetts


Active, not recruiting


University of Massachusetts Chan MedicaL School

Worcester, Massachusetts, 01605

International Sites

University of Puerto Rico, San Juan, Puerto Rico




University of Puerto Rico

San Juan, , 00935

Site Contact

Esther Torres, MD


787-754-0101 #5444